To Evaluate the Efficacy and Safety of Collavant n2 in Individuals With Osteoarthritis of the Knee

NCT05474586 | Completed

• 1 other identifier: BI/210903/COLL/OA
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 10

Brief Summary

A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of Collavant n2 in individuals with osteoarthritis of the knee.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Osteoarthritis Index Pain subscale

  Knee joint pain as assessed by the change in the Western Ontario and McMaster Universities Osteoarthritis Index Pain subscale (WOMAC-P) score. the primary efficacy variable for the present study is the total WOMAC index score, the scores for each subscale will be summed up (Pain range: 0-20, Stiffness range: 0-8, and Physical function range: 0-68). Thus, the total WOMAC score will range from 0 - 96. The lowest the score is the good response and highest the score is extreme pain i.e. bad response.

  Day 0, 7, 30, 60, 90, 120, 150, and 180

Secondary Outcomes (5)

• Knee joint pain as assessed by the change in the Western Ontario and McMaster - Pain subscale score.

  Day 0, 7, 30, 60, 90, 120, 150, and 180

• Knee joint stiffness as assessed by the change in the WOMAC - Stiffness subscale (WOMAC-S) score.

  Day 0, 7, 30, 60, 90, 120, 150, and 180

• Knee joint function as assessed by the change in the WOMAC - Physical function (WOMAC-PF) score.

  Day 0, 7, 30, 60, 90, 120, 150, and 180

• Knee joint pain assessed by the change in the Visual Analogue Scale (VAS) score.

  Day 0, 7, 30, 60, 90, 120, 150, and 180

• Severity of osteoarthritis as assessed by the change in the Lequesne algofunctional index (LAI) score.

  Day 0, 7, 30, 60, 90, 120, 150, and 180

Study Arms (3)

Collavant n2 40 mg/day

EXPERIMENTAL

2 capsules in the morning before breakfast and 2 capsules at night before going to bed for 180 days

Other: Collavant n2 40 mg/day

Glucosamine hydrochloride & Chondroitin sulfate

ACTIVE COMPARATOR

2 capsules in the morning before breakfast and 2 capsules at night before going to bed for 180 days

Other: Glucosamine hydrochloride & Chondroitin sulfate

Microcrystalline cellulose

PLACEBO COMPARATOR

2 capsules in the morning before breakfast and 2 capsules at night before going to bed for 180 days

Other: Microcrystalline cellulose

Interventions

Collavant n2 40 mg/day OTHER

2 capsules in the morning before breakfast and 2 capsules at night before going to bed for 180 days

Collavant n2 40 mg/day

Glucosamine hydrochloride & Chondroitin sulfate OTHER

2 capsules in the morning before breakfast and 2 capsules at night before going to bed for 180 days

Glucosamine hydrochloride & Chondroitin sulfate

Microcrystalline cellulose OTHER

2 capsules in the morning before breakfast and 2 capsules at night before going to bed for 180 days

Microcrystalline cellulose

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and females ≥ 40 to ≤ 75 years suffering from knee joint pain for atleast 3 months before screening.
• Body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
• Pain VAS for knee joint pain ≥ 5 and ≤ 7 cm on a 10 cm scale at screening.
• Radiographic evidence of grade II/III knee OA based on the Kellgren and Lawrence (KL) radiographic entry criteria for OA - i Grade II: Antero-posterior weight-bearing knee radiograph demonstrates possible joint space narrowing (JSN) with definite osteophyte formation.
• ii Grade III: Antero-posterior weight-bearing knee radiograph demonstrates definite joint space narrowing, multiple osteophyte formations, some sclerosis, and possible deformity of bony ends.
• LAI score of ≥ 6 - ≤10 at screening.
• Willing to stop the restricted dietary supplements, home-based remedies, and any other form of topical products or medications for knee joint pain relief or any other reason for the entire study duration.
• (Note: only hot and cold fomentation will be allowed, and the participant has to record the daily frequency of fomentation in the diary. The hot/cold fomentation needs to be stopped 48 hours prior to all assessment visits.)
• Willing to stop using rescue medication 48 hours prior to all assessment visits.
• Using the western toilet at home and/or workplace.
• Willingness to participate and comply with the study procedures and required visits.
• Ability to understand and sign a written informed consent form, which must be completed before performing study-specific tasks.
• Literate and have the ability to complete the study-based questionnaires and tasks.
• Female participants of childbearing age must be willing to use the acceptable methods of contraception during the study.

You may not qualify if:

• History of uncontrolled hypertension and/or systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg. 2 Fasting blood glucose (FBG) \> 125 mg/dl. 3 Radiographic evidence of Grade I or Grade IV OA based on the KL radiographic criteria for osteoarthritis. 4 Any history of trauma, fractures, or surgery to the index joint. 5 Any planned surgery (diagnostic or therapeutic intervention) to the index joint during the participation in the study. 6 History of use of corticosteroid, disease modifying drugs, glucosamine, chondroitin, and intra-articular treatments including injections of corticosteroid or hyaluronic acid within 6 months of the screening visit and consumption of Omega-3 fatty acids or other joint health supplements within 15 days preceding the screening visit. 7 History of use of gabapentin within 6 weeks and/or methylcobalamin within 2 weeks prior to screening. 8 Known case of deformity of the knee joint or diagnosed on clinical examination during screening. 9 Known case of any joint disorder involving the index joint that includes but is not limited to known rheumatic or inflammatory conditions such as rheumatoid arthritis, osteomyelitis, osteoporosis, severe OA, and bone metastasis. 10 Known cases of gout and/or hyperuricemia (serum uric acid \>440 μmol/L). 11 Other pathologic lesions on X-ray of the knee. 12 History of bleeding disorders (e.g., Haemophilia, Sickle cell anaemia, etc.).
• Participants with abnormal levels of serum thyroid-stimulating hormone (TSH) (\< 0.4 to \> 4.2 mIU/L). 14 Any history or evidence of allergy to chicken, eggs, or protein products in the past. 15 Alcoholics or known drug dependents. (Alcoholism or heavy alcohol use is interpreted based on alcohol content consumed per day or week. It is defined as more than 4 drinks on any day or more than 14 drinks per week for men. For women, it is defined as more than 3 drinks on any day or more than 7 drinks per week. Standard alcoholic drink is roughly equivalent to 14 grams of pure alcohol, which is found in the following: i 12 ounces (Approx. 350 ml) of regular beer, which is usually about 5% alcohol ii 5 ounces (Approx. 150 ml) of wine, which is typically about 12% alcohol iii 1.5 ounces (Approx. 45 ml) of distilled spirits, which is about 40% alcohol) 16 History of smoking or currently smoking or using any form of smokeless tobacco. 17 Not willing to abstain from the use of NSAIDs (including low dose aspirin 50 mg/day for cardiovascular health). 18 Participation in a study of an investigational product within 90 days prior to the screening.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (10)

Amber Clinic

Ahmedabad, Gujarat, 380015, India

Location

Prme Orthopedic Speciality

Mumbai, Maharashtra, 400053, India

Location

Diamond Hospital

Mumbai, Maharashtra, 400064, India

Location

Ayush Nursing Home

Mumbai, Maharashtra, 400067, India

Location

Life Care Hospital

Nashik, Maharashtra, 422009, India

Location

Sparsh Hospital

Panvel, Maharashtra, 410206, India

Location

Care n Cure Multispeciality Hospital

Pālghar, Maharashtra, 401209, India

Location

Lifepoint Multispeciality Hospital

Pune, Maharashtra, 411057, India

Location

Imperial Multispecialty Hospital

Pune, Maharashtra, 411062, India

Location

Gayatri Hospital

Vasai, Maharashtra, 401208, India

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Glucosamine; Chondroitin Sulfates; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hexosamines; Amino Sugars; Carbohydrates; Chondroitin; Glycosaminoglycans; Polysaccharides

Study Officials

• Dr Shalini Srivastava, MD medicine

  Vedic Lifesciences Pvt. Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Sequentially numbered, sealed, opaque envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Parallel Group, Placebo Controlled Trial

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: July 26, 2022
• Study Start: August 8, 2022
• Primary Completion: July 4, 2023
• Study Completion: July 4, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Locations

IN (10)